A Multi-center, Open-label, 5-Part Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Aprepitant and Fosaprepitant Dimeglumine in Pediatric Patients Receiving Emetogenic Chemotherapy
- Conditions
- Chemotherapy induced nausea and vomiting (CINV)MedDRA version: 9.1Level: LLTClassification code 10056989Term: Nausea post chemotherapyMedDRA version: 9.1Level: LLTClassification code 10036899Term: Prophylaxis against chemotherapy induced vomiting
- Registration Number
- EUCTR2006-005515-10-DE
- Lead Sponsor
- Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., USA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 92
1. Patient is 6 months to 17 years of age at the time of study entry.
2. Patient is scheduled to receive moderately or highly emetogenic chemotherapy for a documented malignancy as defined OR patient did not tolerate a previously administered chemotherapy regimen, for a documented malignancy, secondary to nausea and/or vomiting that is planned to be repeated.
3. Patient is expected to receive ondansetron as part of their antiemetic regimen.
4. Female patient who has begun menses has a negative urine pregnancy test prior to randomization. Females of reproductive potential who have previously been sexually active must agree to use a double-barrier form of contraception for at least 14 days prior to, throughout, and for at least 1 month following the last dose of study medication. Women taking oral contraception agents must agree to add double barrier form of contraception. Abstinence is also considered an acceptable form of contraception, however, for countries where abstinence is not considered an acceptable form of contraception, two acceptable birth control methods must be used for females of reproductive potential who have previously been sexually active..
5. Patients weight = 7.5 kg.
6. Patient has a preexisting functioning central or venous catheter prior to receiving aprepitant/fosaprepitant designated for pharmacokinetic sampling.
For Parts I and V only: a double lumen central venous catheter or a single lumen central venous catheter (for fosaprepitant administration) along with a peripheral venous catheter (for pharmacokinetic sampling) is required.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Patient is scheduled to receive stem cell rescue therapy in conjunction with study related course(s) of emetogenic chemotherapy.
2. Patient has ever participated in a study with aprepitant or fosaprepitant, is currently participating in a study with casopitant or has taken a non-approved (investigational) drug within the last 4 weeks.
Note: Patients on investigational studies with marketed chemotherapeutic agents (whether marketed explicitly for children or only marketed for adults and usually applied for children as well, with appropriate dosage adjustments) are allowed to enroll if they fulfill all other entry criteria
3. Patient is allergic to aprepitant, fosaprepitant, ondansetron or any other 5 HT3 antagonist.
4. Patient has a symptomatic primary or metastatic CNS malignancy.
5. Patient must meet all satisfy all laboratory value criteria as stated in the protocol.
6. Patient has been treated with specified antiemetic agents within 48 hours prior to Study Day 1.
7. Patient has been started on systemic corticosteroid therapy within 72 hours prior to study drug administration or is planned to receive a corticosteroid as part of their chemotherapy regimen.
Exceptions:
- Patients who are receiving chronic (>72 hours), daily steroid therapy can be enrolled provided the steroid dose is not >0.14 mg/kg up to 10 mg of prednisone daily or equivalent.
- Patients are allowed to receive a single dose of a corticosteroid within 3 days prior (but not on the day of study drug administration) provided it is < the equivalent of 20 mg of prednisone.
- Patients are allowed to receive corticosteroids administered for antiemetic prophylaxis starting on study Day 1.
8. Patient is taking, or has taken within 7 days of study drug administration the following CYP3A4 substrates:
- Terfenadine, cisapride, astemizole, pimozide, and amifostine
9. Patient is taking, or has taken within the 7 days of Treatment Day 1 moderate-to-strong CYP3A4 inhibitors including, but not limited to:
- Clarithromycin, erythromycin, ketoconazole, itraconazole, fluconazole, telithromycin
10. Patient is taking, or has taken within 30 days of Study Day 1 the following CYP3A4 inducers including, but not limited to:
- Barbiturates, rifampicin or rifabutin, phenytoin or carbamazepine, and St. Johns Wort
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method